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RecruitingLast updated: 25 November 2022

Starglo: This phase III trial aims to evaluate the effectiveness of two targeted therapy-chemotherapy combinations in patients with Diffuse Large B-cell LymphomaA Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Clinical summary

Summary

Eligible patients will be randomised to receive Glofit-GemOx or R-GemOx treatment. Patients randomised to receive Glofit-GemOx, will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), followed by up to 4 cycles of glofitamab monotherapy. These patients will also receive a single dose of obinutuzumab 7 days prior to the first dose of glofitamab. Treatment is administered in 21-day cycles. Patients randomised to receive R-GemOx, will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. All treatment will be administered in 21-day cycles.

Conditions

This trial is treating patients with Diffuse Large B-Cell Lymphoma.

Cancer

Blood Cancers Blood

Age

People18+

Phase

III

Trial Acronym

Starglo

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Trial Identifiers

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Commercial Sponsor

Hoffmann-La Roche

Scientific Title

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Eligibility

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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